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MEDTECH Enhanced Dosing Flexibility with Teclistamab: A Leap Forward in Multiple Myeloma Management
The FDA’s recent approval of biweekly dosing for teclistamab marks a significant advancement in the treatment of relapsed/refractory multiple myeloma (R/R MM), offering a new regimen that aligns with patients’ needs for sustained efficacy and manageable scheduling. This approval is based on the robust findings from the MajesTEC-1 trial, demonstrating a promising step forward in personalized cancer therapy.
Key Points:
- The FDA approved biweekly dosing of teclistamab at 1.5 mg/kg for patients with R/R MM who have maintained a complete response or better for at least six months.
- This approval provides a new, less frequent dosing option, increasing treatment flexibility for patients and healthcare providers.
- Teclistamab, a bispecific antibody targeting BCMA and CD3, was initially approved in October 2022 for R/R MM patients based on the MajesTEC-1 trial results.
- Patients eligible for biweekly dosing must have achieved a complete response with weekly dosing of 1.5 mg/kg for at least six months.
- The most common adverse reactions to teclistamab include pyrexia, cytokine release syndrome, and musculoskeletal pain, among others.
- Severe grade 3 to 4 laboratory abnormalities observed in the trial included significant decreases in lymphocytes, neutrophils, white blood cells, hemoglobin, and platelets.
- Johnson & Johnson highlights teclistamab’s unique position as the only BCMA-targeted therapy with weight-based dosing in the context of immune-based treatments for MM.
“Teclistamab is the only BCMA-targeted immune-based therapy with weight-based dosing. Today’s approval of biweekly dosing for eligible patients will further enable clinicians to meet the individual needs of patients who may want flexibility in their dosing schedules.”
– Rachel Kobos, MD, Vice President, Oncology Research & Development, Johnson & Johnson Innovative Medicine
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